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The Maternal and Perinatal Outcomes Associated With the Use of Non-pharmacological in Labor

This study is currently recruiting participants.
Verified June 2012 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Alessandra Cristina Marcolin, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01601860
First received: September 19, 2011
Last updated: June 14, 2012
Last verified: June 2012
History of Changes
  Purpose

Although there are studies that investigated the use of non-pharmacological pain relief and correction of dystocia during labor, there are few randomized controlled trials, especially related to combined protocols that use such resources. The use of combined protocols could potentiate the effects of resource use alone, evidencing the need for more studies related to the topic, as well as the effects of these methods on maternal and perinatal outcomes. In order to verify the effect of these methods in various stages of labor, childbirth and immediately becomes necessary to conduct a randomized controlled trial well-designed and adequate sample size that can make the future systematic reviews that can definitely conclude about the potential effectiveness of protocols that use combined resources to non-pharmacological pain relief in labor. Aim of our study is to evaluate the effects of a protocol of non-pharmacological resources on pain of pregnant women in the active phase of cervical dilatation and compared with controls.


Condition Intervention Phase
Pain
 Other: Use of non-pharmacological
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Maternal and Perinatal Outcomes Associated With the Use of Non-pharmacological in Parturients in Active Phase of Labor

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Evaluation of maternal and perinatal outcomes associated with the use of non-pharmacological [ Time Frame: During labor ] [ Designated as safety issue: No ]
    To assess the effects of a pharmacological protocol features not on the pain of mothers in the active phase of cervical dilatation and compare with controls


Secondary Outcome Measures:
  • To evaluate and compare between groups the number of requests for pharmacological pain relief [ Time Frame: During labor ] [ Designated as safety issue: No ]
    Consider whether the protocol during the active phase of labor postpones the number of request for analgesia use for pain relief for pregnant women

  • To evaluate and compare between groups average cervical dilation at the time of the request pharmacological pain relief is done by pregnant women; [ Time Frame: During labor ] [ Designated as safety issue: No ]
    See if there was a difference between the groups at the time of the request pharmacological pain relief is done by pregnant women;

  • Evaluate and compare between groups the number and types of obstetric complications of mothers [ Time Frame: During labor ] [ Designated as safety issue: No ]
    Observe if the groups were different types of obstetric complications of mothers

  • evaluate and compare between groups the number and types of immediate postpartum maternal morbidities [ Time Frame: During labor ] [ Designated as safety issue: No ]
  • evaluate and compare between groups the number and types of neonatal morbidities [ Time Frame: During Labor ] [ Designated as safety issue: No ]
  • evaluate and compare between the groups in duration of active phase of expansion and the second stage of the mothers [ Time Frame: During labor ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Control Group (CG) Pregnant women who will not use any physical therapy resource, are subject only to routine procedures of maternity care Pregnant women who will not use any physical therapy resource, are subject only to routine procedures of maternity care
Experimental: Protocol
Intervention Group (IG) Pregnant women who will use the following features sequentially: walking (with cervical dilation between 4 and 5 cm), alternating stance associated with ENT (cervical dilatation from 6 to 7 cm), shower (with dilation> 7 cm);
 Other: Use of non-pharmacological
Evaluation of maternal and perinatal outcomes associated with the use of non-pharmacological

Detailed Description:

Labor is a natural physiologic process triggered by mechanical and hormonal events that promote uterine contractions. Several non-pharmacological resources can be used during labor, such as relaxation techniques and ongoing support, maternal mobility, walking, breathing exercises, massage, Swiss ball, stool, shower, whirlpool and application of transcutaneous electrical stimulation (ENT .) Despite the role of physiotherapy in labor is not an established practice in public hospitals, it is expected that with the evidence of the benefits of non-pharmacological resources at this time, managers and health professionals validate the importance of interdisciplinary care in pregnancy - postpartum. The aim of this study is to evaluate the effects of resources on non-pharmacological pain of mothers in the active phase of cervical dilatation when compared to controls. This research is a randomized, controlled clinical study that includes pregnant women randomly assigned to two groups: Intervention Group (IG) women who will use the following sequence features: ambulation (with cervical dilatation of 4 to 5 cm), alternating stance associated with ENT (cervical dilatation from 6 to 7 cm) and a shower (with dilation> 7 cm) for 40 minutes each resource; Control Group (CG) women who will not use any physical therapy resource, are subject only to routine procedures of maternity care . For pain assessment will use the Visual Analogue Scale - VAS and the body diagram of the location and spatial distribution of pain. Results are presented in tables and graphs made to better understand the comparisons between the control and intervention. To compare maternal morbidity, obstetric and neonatal between groups will be used Fisher's exact test or chi-square.

  Eligibility

Ages Eligible for Study:   15 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Agreement of the patient to participate in the study after reading and signing the consent form;

    • primigravida;
    • Pregnancy unique;
    • Gestational age> 37 weeks;
    • fetal cephalic presentation;
    • chorioamniotic intact membranes;
    • spontaneous labor;
    • Admission to the beginning of the active phase of dilatation (4 cm cervical dilatation);
    • Dynamics between 2 and 4 uterine contractions in ten minutes;
    • Lack of maternal and fetal pathologies;
    • literate;
    • Absence of cognitive problems.

Exclusion Criteria:

Intolerance to non-pharmacological application of resources;

  • Increased pain by the woman that prevents the completion of the intervention;
  • Want to stop the intervention;
  • Suspected acute suffering;
  • Indication of cesarean section.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01601860

Contacts
Contact: Alessandra Marcolin, Prof 55 (16) 36022587 amarcolin@fmrp.usp.br
Contact: Licia Santana, Master 55 (16) 36022587 licia_san@hotmail.com

Locations
Brazil
Professor, Department of Gynecology and Obstetrics, Faculty of Medicine of Ribeirão Preto, University of São Paulo. Recruiting
Ribeirão Preto, São Paulo, Brazil
Contact: Alessandra C Marcolin, Professor     (16) 36022587 ext 55     amarcolin@fmrp.usp.br    
Contact: Licia S Santana, Master     (16) 36022587 ext 55     licia_san@hotmail.com    
Sub-Investigator: Licia S Santana, Mater            
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Alessandra C Marcolin, Professor Faculty of Medicine of São Paulo University
  More Information

Publications:

Responsible Party: Alessandra Cristina Marcolin, Prof. Dra., University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01601860     History of Changes
Other Study ID Numbers: FR444841
Study First Received: September 19, 2011
Last Updated: June 14, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Labor
vaginal delivery
pain

ClinicalTrials.gov processed this record on May 22, 2013